Retsevmo

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

Selpercatinib

Saadav alates:

Eli Lilly Nederland B.V.

ATC kood:

L01EX22

INN (Rahvusvaheline Nimetus):

selpercatinib

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Carcinoma, Non-Small-Cell Lung; Thyroid Neoplasms

Näidustused:

Retsevmo as monotherapy is indicated for the treatment of adults and adolescents 12 years and older with advanced RET-mutant medullary thyroid cancer (MTC)advanced RET fusion-positive non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitoradvanced RET fusion-positive thyroid cancer who require systematic therapy following prior treatment

Toote kokkuvõte:

Revision: 8

Volitamisolek:

Authorised

Loa andmise kuupäev:

2021-02-11

Infovoldik

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RETSEVMO 40 MG HARD CAPSULES
RETSEVMO 80 MG HARD CAPSULES
selpercatinib
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
-
This leaflet has been written as though the person taking the medicine
is reading it. If you are
giving this medicine to your child, please replace “you” with
“your child” throughout.
WHAT IS IN THIS LEAFLET
1.
What Retsevmo is and what it is used for
2.
What you need to know before you take Retsevmo
3.
How to take Retsevmo
4.
Possible side effects
5.
How to store Retsevmo
6.
Contents of the pack and other information
1.
WHAT RETSEVMO IS AND WHAT IT IS USED FOR
Retsevmo is an anticancer medicine containing the active substance
selpercatinib.
It is used to treat the following cancers which are caused by certain
abnormal changes in the RET gene
and which have spread and/or cannot be removed by surgery:
-
A type of lung cancer called non-small cell lung cancer, in adults who
have not previously been
treated with a
_RET _
inhibitor medicine.
-
Thyroid cancer (any type) in adults and adolescents 12 years and older
if radioactive iodine
treatment, when appropriate, has failed to control your cancer.
-
A rare type of thyroid cancer called medullary thyroid cancer in
adults and adolescents 12 years
an

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Retsevmo 40 mg hard capsules
Retsevmo 80 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Retsevmo 40 mg hard capsules
Each hard capsule contains 40 mg selpercatinib.
Retsevmo 80 mg hard capsules
Each hard capsule contains 80 mg selpercatinib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules.
Retsevmo 40 mg hard capsules
Grey opaque capsule, 6 x 18 mm (size 2), imprinted with “Lilly”,
“3977” and “40 mg” in black ink.
Retsevmo 80 mg hard capsules
Blue opaque capsule, 8 x 22 mm (size 0), imprinted with “Lilly”,
“2980” and “80 mg” in black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Retsevmo as monotherapy is indicated for the treatment of adults with:
–
advanced
_RET_
fusion-positive non-small cell lung cancer (NSCLC) not previously
treated with
a
_RET_
inhibitor
Retsevmo as monotherapy is indicated for the treatment of adults and
adolescents 12 years and older
with:
–
advanced
_RET_
fusion-positive thyroid cancer who are radioactive iodine-refractory
(if
radioactive iodine is appropriate)
–
advanced
_RET_
-mutant medullary thyroid cancer (MTC)
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Retsevmo therapy should be initiated and supervised by physicians
experienced in the use of
anti-cancer therapies.
RET testing
The presence of a
_RET _
gene fusion (NSCLC and non-medullary thyroid cancer) or mutation (MTC)
should be confirmed by a validated test prior to initiation of
treatment with Retsevmo.
Posology
The recommended dose of Retsevmo based on body weight is:
-
Less than 50 kg: 120 mg twice daily.
-
50 kg or greater: 160 mg twice daily.
If a patient vomits or misses a dose, the patient should be